Safety and Efficacy of RAP-103 to Improve Severity and Quality of Life on Moderate to Severe Psoriasis in Subjects

• Status: NOT_YET_RECRUITING
• Trial end date: 2025-12-30

Summary

Randomized, controlled trial, Proof of Concept, Phase 2 aimed to evaluate the effect of RAP-103 in dose of 400mg/day/one dose a day, 200mg/day twice dose a day, or placebo administrated for 8 weeks to improve Psoriasis Area and Severity Index (PASI)75 or static Physician's Global Assessment (sPGA) score of 0 or 1; PASI50, PASI90, PASI100, Scalp-specific Physician's Global Assessment (Ss-PGA) 0/1 with at least a 2-point improvement among patients with a baseline ss-PGA 3, sPGA 0, PSSD symptom score of 0 among patients with baseline score 1, Dermatology Life Quality Index (DLQI) 0/1 at Week 4 and 8 among patients with baseline DLQI 2, adjusted by transcriptomics profile (post-hoc analysis), Percentage of subjects which achieve The Minimum Clinically Important Difference (MCID) on DLQI (a 4-point reduction from baseline) at Week 4 and 8, Frequency of solicited and unsolicited adverse events (SAEs and USAEs) (Medra), and Changes on inflammatory and anti-inflammatory cytokine levels during treatment (IL-17, IL-23, IL-6, TNF-alpha, IL1-b, IL-10).

• Phase: PHASE2

Details

• Lead Sponsor: Clarent Biopharma, Inc.
• Collaborators: Elemental CRO; Elemental Traslational Research SAPI; Innovacion y Desarrollo de Estrategias en Salud
• Treatments: BID protein, human; RAP-103